Medicare Patients in North Carolina, South Carolina, West Virginia
and Virginia Now Have a New Minimally Invasive Treatment Option for
Reflux Disease

REDMOND, Wash.--(BUSINESS WIRE)--EndoGastric
Solutions® (EGS), a leader in incisionless procedural therapy
for gastroesophageal reflux disease (GERD), is pleased to announce that
Medicare Administrative contractor Palmetto
GBA, LLC has approved reimbursement of the company’s Transoral
Incisionless Fundoplication (TIF®) 2.0 procedure for Medicare patients
across the Carolinas, Virginia and West Virginia. Palmetto GBA, based in
Columbia, South Carolina, is one of the nation’s largest providers of
high volume claims and transaction processing, contact center operations
and technical services to the federal government and other commercial
customers. This decision will affect approximately 4.4 million Medicare
patients across the region.

“Patients suffering from chronic GERD need a third option other than
medications, which mask the symptoms of the condition, and traditional
surgery with its known side effects,” says Karim Trad, MD, Clinical
Professor of Surgery at George Washington University School of Medicine
and principal investigator in the TIF 2.0 clinical study. He further
explains how the TIF 2.0 procedure works, “Utilizing the EsophyX®
device, a tool designed to rebuild the antireflux valve and restore the
body’s natural protection against acid reflux, the TIF 2.0 procedure
offers patients durable relief from GERD symptoms.”

“Approximately one in four Americans suffer from GERD, and the TIF 2.0
procedure has already helped more than 18,000 patients worldwide treat
their chronic GERD,” says Skip Baldino, CEO, EndoGastric Solutions. “We
are grateful for partners like Palmetto, who are helping us address an
unmet clinical need by making the TIF 2.0 procedure more accessible for
Medicare patients.”

The TIF 2.0 procedure was made available with Palmetto on November 28,
2016, and patients and providers can reference Category 1 CPT® code
43210 for coverage opportunities. For more information on the TIF 2.0
procedure, please visit http://www.endogastricsolutions.com/tif-procedure/.

The positive coverage decision follows publication of three-year follow
up data from TIF EsophyX
vs Medical PPI Open
Label (TEMPO), a prospective, randomized, multicenter clinical study,
which demonstrated long-term control of chronic GERD after a TIF 2.0
procedure with the EsophyX® device. The study met its primary endpoint,
with 83 percent of patients undergoing the TIF procedure experiencing
elimination of regurgitation and all atypical GERD symptoms at
three-years post-procedure. The Surgical Endoscopy open access
paper is available here.
The TIF 2.0 procedure has also been supported by over 70 additional
published studies that consistently report positive clinical outcomes.

Additional Medicare Administrator Contractors with confirmed coverage
for the TIF procedure include: Cahaba
Government Benefit Administrators,® LLC for over three million
members in Alabama, Georgia and Tennessee, CGS Administrators®, LLC
which serves 2.7 million members in Kentucky and Ohio, and Novitas
Solutions, Inc. which covers over nine million members in Arkansas,
Colorado, Louisiana, Mississippi, New Mexico and Oklahoma.

Earlier this year, Health Care Service Corporation (HCSC) provided
coverage for approximately 15 million members through its affiliates;
Blue Cross Blue Shield of Illinois, Blue Cross Blue Shield of Montana,
Blue Cross Blue Shield of New Mexico, Blue Cross Blue Shield of Oklahoma
and Blue Cross Blue Shield of Texas.

About Current Procedural Terminology (CPT®)

CPT codes are a listing of descriptive terms and identifying codes for
reporting medical services and procedures. The purpose of CPT is to
provide a uniform language that accurately describes medical, surgical,
and diagnostic services, and thereby serves as an effective means for
reliable nationwide communication among physicians and other healthcare
providers, patients and third parties. CPT is registered trademark of
the American Medical Association.

Gastroesophageal reflux disease (GERD) is a chronic condition in which
the gastroesophageal valve (GEV) allows gastric contents to reflux (wash
backwards) into the esophagus, causing heartburn and possible injury to
the esophageal lining. GERD is the most common gastrointestinal-related
diagnosis made by physicians during clinical visits in the U.S. It is
estimated that pain and discomfort from acid reflux impacts over 80
million people at least once per month in the U.S. The standard
recommendations for symptomatic GERD patients include lifestyle changes
(e.g., diet, scheduled eating times and sleeping positions) and
escalating doses of prescription medications for prolonged periods of
time. Long-term, maximum-dose usage of prescription medications has been
linked to a variety of other health complications.

Performed without the need for external incisions through the skin, the
TIF procedure offers patients who require an anatomical repair an
effective treatment option to correct the underlying cause of GERD.
Studies show that for up to three years after the TIF procedure,
esophageal inflammation (esophagitis) is eliminated and most patients
are able to stop using daily medications to control symptoms.

Over 18,000 TIF patients have been treated worldwide since the
EsophyX® device was launched. In the past ten years, more than 70
peer-reviewed papers from over 50 centers have been published
documenting consistent outcomes on over 1,100 unique study
patients. For more information, visit www.GERDHelp.com.

About EsophyX® technology

The EsophyX technology is used to reconstruct the gastroesophageal valve
(GEV) and restore its function as a barrier, preventing stomach acids
refluxing back into the esophagus. The device is inserted through the
patient’s mouth with direct visual guidance from an endoscope. The
original EsophyX device was cleared by the FDA in 2007. EndoGastric
Solutions® launched the third generation EsophyX device, the EsophyX Z,
in 2015. The evolving EsophyX technology now enables surgeons and
gastroenterologists to use a wider selection of endoscopes – including
low profile and larger high-definition models — to treat the underlying
anatomical cause of GERD.

Indications

The EsophyX device with SerosaFuse fasteners is indicated for use in
transoral tissue approximation, full thickness plication and ligation in
the GI tract and is indicated for the treatment of symptomatic chronic
GERD in patients who require and respond to pharmacological therapy. It
is also indicated to narrow the gastroesophageal junction and reduce
hiatal hernia ≤ 2cm in size in patients with symptomatic chronic GERD.

About EndoGastric Solutions®

Based in Redmond, WA, EndoGastric Solutions, Inc. (www.endogastricsolutions.com),
is a medical device company focused on developing and commercializing
innovative, evidence-based, incisionless surgical technology for the
treatment of GERD. EGS has combined the most advanced concepts in
gastroenterology and surgery to develop the Transoral Incisionless
Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that
addresses a significant unmet clinical need.